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Tocilizumab

RoActemra

Extended indication Treatment of adult giant cell arteritis.
Therapeutic value No judgement
Total cost 14,700,000.00

Product

Active substance Tocilizumab
Domain Chronic immune diseases
Main indication Cardiovascular diseases
Extended indication Treatment of adult giant cell arteritis.
Proprietary name RoActemra
Manufacturer Roche
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date November 2016
Expected Registration September 2018
Orphan drug No
Additional remarks Indicatie-uitbreiding

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times a week
Dosage per administration 162 mg
References Lopende studies fase 3 op clinicaltrials.gov

Expected patient volume per year

Patient volume

600 - 1,500

Market share is generally not included unless otherwise stated.
Additional remarks Aangezien het een grote innovatie is wordt wel verwacht dat het aantal patienten groter is dan 60 met een max. van 600 is. Werkgroep: 1000-1500 patiënten.

Expected cost per patient per year

Cost < 14,000.00
References Fabrikant
Additional remarks € 155 per 80 mg flacon

Potential total cost per year

Total cost

14,700,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.